FDA Announces Stricter Rules for Sunscreen Labeling

Labeling on sunscreen bottles is about to get a whole lot less confusing. The U.S. Food and Drug Administration (FDA) announced on Tuesday stricter new rules for sunscreen manufacturers’ claims of sun protection, including new provisions that will allow labels to maintain for the first time that products can help reduce the risk of skin cancer and early skin aging.

The rules, which the FDA has been considering since 1978, will go into effect by next summer. They will require sunscreen manufacturers to test their products’ effectiveness against two types of the sun’s ultraviolet rays: UVA and UVB. UVB rays are largely responsible for sunburn; both UVA and UVB rays cause skin wrinkling and cancer.

Sunscreens that effectively protect against both types of rays will be labeled as providing “broad spectrum” protection. Sunscreens that are both broad spectrum and have a sun protection factor, or SPF, of 15 or higher will be permitted to claim that they help reduce the risk of skin cancer and premature skin aging.

Any product that has an SPF of 2 to 14 or doesn’t meet the broad spectrum standard must include a warning saying it hasn’t been shown to reduce the risks of cancer or skin aging.

The FDA has also proposed doing away with SPF designations above 50, because there’s no evidence that sunscreens with such high SPFs offer better protection. The agency has asked for further data and public comment on the matter. “Right now, we don’t have any data to show that anything above 50 adds any value for anybody,” Dr. Janet Woodcock, director of the FDA’s drug center, told the New York Times.

The new rules will also prohibit manufacturers from claiming their products are “waterproof” or “sweatproof” because those terms are misleading. Instead, sunscreens may be labeled as “water resistant” and must indicate how long in minutes — 40 minutes or 80 minutes — they maintain sun protection while swimming or sweating, based on standardized tests.

Recently, the Environmental Working Group rated sunscreens for both safety (based on their toxic chemical load) and effectiveness (based on how well they protect against UVA and UVB rays). The FDA’s new guidelines address the latter concern, but the agency said it would continue to explore the safety question. According to the Times’ Gardiner Harris:

The F.D.A. announced that it was re-examining the safety of the roughly 17 sunscreen agents approved for use in the United States, although it has no information to suggest that they are not safe. … Some consumer and environmental groups have expressed concern that the ingredients in some sunscreens have been made so microscopic that they could be absorbed through the skin into the body, but Dr. Woodcock said that the F.D.A.’s own tests had found no cause for such concerns.

The agency is also asking for more information about sunscreen sprays to ensure that consumers get adequate quantities from spray bottles and to explore what happens when those products are inhaled. “You could imagine a child getting a sunscreen sprayed on and turning their face into the blast and breathing it in,” Dr. Woodcock said. “It’s a question of safety.”

More than 1 million Americans are diagnosed with basal cell and squamous cell skin cancer, the two most common types of skin cancer, each year. More than 68,000 are diagnosed with melanoma, which is the deadliest type of skin cancer, according to the National Cancer Institute.

“Most skin cancers are caused by sun exposure. FDA encourages consumers to protect themselves,” Dr. Woodcock said in a statement. “Not only should consumers regularly apply and reapply sunscreens with broad spectrum and SPF of 15 or higher, they should also limit sun exposure.”